Study on Pembrolizumab and Chemotherapy for Head and Neck Cancer

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05420948

Provider View

This clinical trial is exploring whether a blood test that measures tumor DNA can help guide the use of chemotherapy combined with immunotherapy for people with head and neck cancer. The study aims to see if adding occasional chemotherapy to immunotherapy is more effective than using immunotherapy alone. Participation will last about two years.

Patient Parameters

Program Overview

The study aims to find out if a blood test that measures tumor DNA can help decide how to use chemotherapy with immunotherapy for head and neck cancer. Researchers want to see if adding occasional chemotherapy to immunotherapy works better than just using immunotherapy. The study will last about two years and will look at how well this new treatment strategy works and its safety. All drugs used are FDA-approved but are being combined in a new way based on changes in tumor DNA, which is only done in research.

Description

This study is testing a new approach to treating head and neck cancer by using a blood test to measure tumor DNA. The goal is to see if this test can help guide the use of chemotherapy and immunotherapy together. Researchers want to know if adding chemotherapy occasionally to immunotherapy is more effective than using immunotherapy alone. The study will last about two years and will evaluate the safety and effectiveness of this treatment strategy. All the drugs used are approved by the FDA, but they are being combined in a new way based on changes in tumor DNA, which is only done in research settings.

Eligibility Criteria

Inclusion Criteria

  • Have head and neck cancer that has come back or spread to other parts of the body.
  • Have not had previous systemic therapy for recurrent or metastatic cancer, unless it was completed over 3 months ago for locally advanced disease.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1.
  • Have measurable disease based on specific criteria.
  • Have normal organ and bone marrow function based on lab tests.
  • Provide a tissue sample for PD-L1 biomarker analysis from a biopsy.
  • Sign a study-specific informed consent form.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

  • Have cancer that can be treated with local therapy aimed at a cure.
  • Have disease progression within 3 months of completing curative treatment for advanced cancer.
  • Be receiving other investigational agents.
  • Have tumor DNA that cannot be measured at baseline.
  • Have had recent radiation therapy or not fully recovered from previous treatments.
  • Have active autoimmune or inflammatory disorders requiring immunosuppressive therapy, except for certain conditions like vitiligo or stable hypothyroidism.
  • Have a life expectancy of less than 3 months or rapidly progressing disease.
  • Have another active cancer, except for certain non-threatening types.
  • Have known brain metastases.
  • Have had an organ transplant.
  • Have allergies to similar drugs used in the study.
  • Have received prior anti-PD1 therapy.
  • Have uncontrolled illnesses or psychiatric conditions.
  • Have a history of pneumonitis requiring steroids.
  • Be pregnant or breastfeeding.
  • Be HIV-positive on antiretroviral therapy.
  • Have active Hepatitis B or C, unless eradicated.
  • Have a history of active infection requiring systemic therapy.
  • Have received a live vaccine within 28 days of starting the study, except for COVID-19 vaccines.

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